Pathlab Inc

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on lack of accuracy verification documentation for review and interview with the laboratory director (LD), the laboratory failed to verify the accuracy of testing performed under the subspecialty of Cytology at least twice annually during 2024. Findings include: 1. No documentation was presented for review to indicate the laboratory verified the accuracy of the microscopic interpretation of cytology specimens at least twice annually during 2024. 2. The LD interviewed on 3/11/25 at 3: 03 PM confirmed the laboratory failed to verify the accuracy of the testing indicated above at least twice annually during 2024. 3. The laboratory's reported annual test volume under the specialty of Pathology is 430. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- This STANDARD is not met as evidenced by: Based on lack of humidity records for review from 1/02/2023 through 3/11/2025 and interview with the laboratory director (LD), (A) the laboratory failed to monitor and document the ambient humidity of the room where histopathology specimens are processed, and (B) the laboratory failed to monitor and document the temperature of the room where patient testing occurred on 20 out of 20 testing dates in September 2024. Findings include: 1. The laboratory performs the processing, gross examination and microscopic interpretation of patient specimens in the subspecialties of Histopathology and Cytology with an annual test volume of 430. The laboratory performs testing on each weekday, excluding holidays. A2. The laboratory utilizes the Tissue-Tek Prisma Plus Automatic Stainer to stain histopathology specimens. The manufacturer's environmental operating requirements for the stainer indicates an ambient humidity range of 30-85%. A3. The laboratory failed to monitor and document the ambient humidity of the room where specimen processing occurred on each testing day from 1/02/23 through the survey date on 3/11/25. A4. The LD interviewed on 3/11/25 at 3:30 PM confirmed the laboratory failed to monitor and document the ambient humidity as indicated above. B1. The laboratory failed to monitor and document the room temperature of the laboratory on 20 out of 20 testing dates in September 2024. B2. The LD interviewed on 3/11/25 at 3:25 PM confirmed that laboratory staff failed to monitor and document the room temperature of the laboratory on each testing date during September 2024. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e)(2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. This STANDARD is not met as evidenced by: Based on lack of Quality Control (QC) documentation, review of cytology and histopathology test reports and interview with the laboratory director (LD), the laboratory failed to document the acceptability of Hematoxylin & Eosin (H&E) and Papanicolaou staining materials each day of use, for intended reactivity and to ensure predictable staining characteristics on 2 out of 2 testing dates reviewed during the survey Findings include: 1. The laboratory performs testing under the specialty of Pathology with a reported annual test volume of 430. 2. Review of the histopathology test report for accession# S24-003401 revealed the laboratory failed to document the acceptability of the H&E stain on 1 out of 1 testing dates (9/24/24) reviewed during the survey. 3. Review of the cytopathology test report for accession# CN24-000340 revealed the laboratory failed to document the acceptability of the Papanicolaou stain on 1 out of 1 testing dates (9/25/24) reviewed during the survey. 4. The number of pathology cases read and diagnosed by the laboratory on 9/24/24 and 9/25/24 could not be determined at the time of the survey. 5. The LD interviewed on 3/11/2025 at 2: 45 PM confirmed the laboratory failed to document the H&E and Papanicolaou stain acceptability each day of use for intended reactivity and to ensure predictable staining characteristics on the testing dates indicated above. D5805 TEST REPORT CFR(s): 493.1291(c) (c) The test report must indicate the following: (c)(1) For positive patient -- 2 of 3 -- identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of patient test reports for testing performed in the specialty of Pathology and interview with the laboratory director (LD), one out of one histopathology test report and one out of one cytology test report failed to include the name and the address of the laboratory where the testing was performed. Findings include: 1. The laboratory performs testing in the specialty of Pathology with a reported annual test volume of 430. 2. One out of one histopathology test report (S24- 003401) and one out of one cytology test report (CN24-000340) was missing the laboratory name and address where the testing was performed and the final diagnosis was issued. 3. The LD interviewed on 3/11/25 at 2:10 PM confirmed that the laboratory name and address where the diagnosis was made was not indicated on the patient test reports issued by the laboratory, as indicated above. D6102 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(12) (e)(12) Ensure that prior to testing patients specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results; This STANDARD is not met as evidenced by: Based on lack of initial training documentation for one testing personnel (TP-3) and interview with testing personnel (TP-2), the laboratory director failed to ensure that all testing personnel receive the appropriate training and demonstrate that they can perform all testing operations reliably and accurately prior to testing patients' specimens. Findings include: 1. No initial training documentation was presented for review for one testing personnel (TP-3) who performs the gross examination of cytology specimens in the specialty of Pathology. 2. TP-2 interviewed on 3/11/25 at 1: 35 PM confirmed the laboratory failed to have documentation of initial training for the testing personnel indicated above. 3. The laboratory's reported annual test volume for the specialty of Pathology is 430. -- 3 of 3 --

Summary Statement of Deficiencies D6171 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1489(b) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located or have earned a doctoral, master's or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; (b)(2)(i) Have earned an associate degree in a laboratory science, or medical laboratory technology from an accredited institution or-- (b)(2)(ii) Have education and training equivalent to that specified in paragraph (b)(2)(i) of this section that includes-- (b)(2)(ii)(A) At least 60 semester hours, or equivalent, from an accredited institution that, at a minimum, include either-- (b)(2)(ii)(A)(1) 24 semester hours of medical laboratory technology courses; or (b)(2)(ii)(A)(2) 24 semester hours of science courses that include-- (b)(2) (ii)(A)(2)(i) Six semester hours of chemistry; (b)(2)(ii)(A)(2)(ii) Six semester hours of biology; and (b)(2)(ii)(A)(2)(iii) Twelve semester hours of chemistry, biology, or medical laboratory technology in any combination; and (b)(2)(ii)(B) Have laboratory training that includes either of the following: (b)(2)(ii)(B)(1) Completion of a clinical laboratory training program approved or accredited by the ABHES, the CAHEA, or other organization approved by HHS. (This training may be included in the 60 semester hours listed in paragraph (b)(2)(ii)(A) of this section.) (b)(2)(ii)(B)(2) At least 3 months documented laboratory training in each specialty in which the individual performs high complexity testing. (b)(3) Have previously qualified or could have qualified as a technologist under 493.1491 on or before February 28, 1992; (b) (4) On or before April 24, 1995 be a high school graduate or equivalent and have either-- (b)(4)(i) Graduated from a medical laboratory or clinical laboratory training program approved or accredited by ABHES, CAHEA, or other organization approved by HHS; or (b)(4)(ii) Successfully completed an official U.S. military medical laboratory procedures training course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); (b)(5)(i) Until September 1, 1997-- (b)(5)(i)(A) Have earned a high Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- school diploma or equivalent; and (b)(5)(i)(B) Have documentation of training appropriate for the testing performed before analyzing patient specimens. Such training must ensure that the individual has-- (b)(5)(i)(B)(1) The skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation and storage of specimens; (b)(5)(i)(B)(2) The skills required for implementing all standard laboratory procedures; (b)(5)(i)(B)(3) The skills required for performing each test method and for proper instrument use; (b)(5)(i)(B)(4) The skills required for performing preventive maintenance, troubleshooting, and calibration procedures related to each test performed; (b)(5)(i)(B)(5) A working knowledge of reagent stability and storage; (b)(5)(i)(B)(6) The skills required to implement the quality control policies and procedures of the laboratory; (b)(5)(i)(B)(7) An awareness of the factors that influence test results; and (b)(5)(i)(B)(8) The skills required to assess and verify the validity of patient test results through the evaluation of quality control values before reporting patient test results; and (b)(5)(i)(B)(8)(ii) As of September 1, 1997, be qualified under 493.1489(b)(1), (b)(2), or (b)(4), except for those individuals qualified under paragraph (b)(5)(i) of this section who were performing high complexity testing on or before April 24, 1995; (b)(6) For blood gas analysis-- (b)(6) (i) Be qualified under 493.1489(b)(1), (b)(2), (b)(3), (b)(4), or (b)(5); (b)(6)(ii) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; or (b)(6)(iii) Have earned an associate degree related to pulmonary function from an accredited institution; or (b)(7) For histopathology, meet the qualifications of 493.1449 (b) or (l) to perform tissue examinations. This STANDARD is not met as evidenced by: Based on the education documentation presented for review during the survey for one testing personnel (TP-3) and interview with the facility personnel, the laboratory failed to ensure that testing personnel have the required education qualifications prior to testing patients' specimens. Findings include: 1. The laboratory performs approximately 1,574 patient tests annually under the specialty of Pathology. 2. During the survey performed on February 27, 2023, the CMS-209, Laboratory Personnel form submitted for review listed a total of three testing personnel who perform the gross examination on patient specimens. Testing Personnel (TP-3) began patient testing on May 18, 2022. 3. No documentation was presented for review during the survey to indicate that TP-3 referenced above met the required qualifications under 493.1489 for Testing Personnel who perform high complexity testing. 4. The education credentials presented for review for TP-3 failed to include evidence of at least 60 semester hours from an accredited institution that include 24 semester hours of science courses including six semester hours of chemistry; six semester hours of biology; and twelve semester hours of chemistry, biology, or medical technology in any combination. 5. The facility personnel interviewed on 2/27/2023 at 1:10pm acknowledged that the testing personnel stated above lacked the appropriate education documentation for the complexity of testing performed by the laboratory. -- 2 of 2 --

Summary Statement of Deficiencies D0000 In all areas reviewed the Laboratory was found to be in compliance with the requirements of 42 CFR Part 493, Requirements for Laboratory Services, on the day of the survey. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --